Mediterranean Diet and Postprandial Lipemia - Full Text View

Sponsored by:	Federico II University
Information provided by:	Federico II University
ClinicalTrials.gov Identifier:	NCT00789295

Purpose

The aim of this intervention study was to evaluate in type 2 diabetic patients the effects on postprandial lipemia and other metabolic parameters (in both everyday life conditions and after a standard test meal) of two diets, one moderately rich in CHO, rich in fibre and with a low glycemic index (Mediterranean diet), and the other low in CHO and rich in MUFA (Low-CHO diet).Since adipose tissue, mainly through its lipolytic activities, is considered as having a pivotal role in the regulation of postprandial lipid metabolism, a further aim of our study was to clarify the role of adipose tissue in modulating the postprandial lipid response induced by the two dietary approaches by evaluating the activities of lipoprotein lipase (LPL) and hormone-sensitive lipase (HSL).

Condition	Intervention
Postprandial Lipemia Type 2 Diabetes	Other: Mediterranean diet and Low-Carbohydrates diet

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment
Official Title:	Mediterranean vs. Low-Carbohydrate Diet : Which is the Best Dietary Approach for Treating Postprandial Lipid Abnormalities and Improving Glucose Control in Type 2 Diabetic Patients?

Further study details as provided by Federico II University:

Primary Outcome Measures:

Postprandial response triglyceride of chylomicrons and large VLDL [ Time Frame: 4 weeks ]

Secondary Outcome Measures:

Blood glucose and insulin response to test meal [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Lipolytic activities [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Study Start Date:

March 2004

Arms	Assigned Interventions
Mediterranean diet: Active Comparator The Mediterranean diet: relatively rich in Carbohydrate(52% of the total daily energy intake), rich in dietary fibre (28g/1000 kcal both of soluble and unsoluble types) and with a low glycemic index (51%)	Other: Mediterranean diet and Low-Carbohydrates diet The Mediterranean diet: relatively rich in Carbohydrate(52% of the total daily energy intake), rich in dietary fibre (28g/1000 kcal both of soluble and unsoluble types) and with a low glycemic index (51%) versus Low-carbohydrates diet : diet rich in MUFA (23%), relatively low in CHO (45%), low in dietary fibre (8g/1000 kcal) and with a relatively high glycemic index (87%)for 4 weeks
Low-Carbohydrates diet: Active Comparator Low-carbohydrates diet : diet rich in MUFA (23%), relatively low in CHO (45%), low in dietary fibre (8g/1000 kcal) and with a relatively high glycemic index (87%)	Other: Mediterranean diet and Low-Carbohydrates diet The Mediterranean diet: relatively rich in Carbohydrate(52% of the total daily energy intake), rich in dietary fibre (28g/1000 kcal both of soluble and unsoluble types) and with a low glycemic index (51%) versus Low-carbohydrates diet : diet rich in MUFA (23%), relatively low in CHO (45%), low in dietary fibre (8g/1000 kcal) and with a relatively high glycemic index (87%)for 4 weeks

Arms

Assigned Interventions

Mediterranean diet: Active Comparator

The Mediterranean diet: relatively rich in Carbohydrate(52% of the total daily energy intake), rich in dietary fibre (28g/1000 kcal both of soluble and unsoluble types) and with a low glycemic index (51%)

Other: Mediterranean diet and Low-Carbohydrates diet

The Mediterranean diet: relatively rich in Carbohydrate(52% of the total daily energy intake), rich in dietary fibre (28g/1000 kcal both of soluble and unsoluble types) and with a low glycemic index (51%) versus Low-carbohydrates diet : diet rich in MUFA (23%), relatively low in CHO (45%), low in dietary fibre (8g/1000 kcal) and with a relatively high glycemic index (87%)for 4 weeks

Low-Carbohydrates diet: Active Comparator

Low-carbohydrates diet : diet rich in MUFA (23%), relatively low in CHO (45%), low in dietary fibre (8g/1000 kcal) and with a relatively high glycemic index (87%)

Other: Mediterranean diet and Low-Carbohydrates diet

The Mediterranean diet: relatively rich in Carbohydrate(52% of the total daily energy intake), rich in dietary fibre (28g/1000 kcal both of soluble and unsoluble types) and with a low glycemic index (51%) versus Low-carbohydrates diet : diet rich in MUFA (23%), relatively low in CHO (45%), low in dietary fibre (8g/1000 kcal) and with a relatively high glycemic index (87%)for 4 weeks

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes
Stable metabolic control (HbA1c<8.0%) on diet or diet alone or diet+metformin
BMI<30 kg/m2 and body weight stable during the last six months.
Both sexes; only post-menopausal women.
Normal fasting lipid levels
No use of hypolipidemic drugs

Exclusion Criteria:

Patient with renal (serum creatinine >1.5 mg/dl) or hepatic (serum transaminases >three times upper normal values) impairment.
Patients with history of cardiovascular disease.
Pre-menopausal women.
Any other acute or chronic degenerative disease.
Anemia (Hb<12 g/dl).
Uncontrolled blood pressure.
Use of any drugs able to interfere with the study medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789295

Locations

Italy
Department of Clinical and Experimental Medicine, Federico II University Hospital,
Naples, Italy, 80100

Sponsors and Collaborators

Federico II University

Investigators

Study Chair:

Gabriele Riccardi, Prof

Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy

More Information

Publications:

Rivellese AA, De Natale C, Di Marino L, Patti L, Iovine C, Coppola S, Del Prato S, Riccardi G, Annuzzi G. Exogenous and endogenous postprandial lipid abnormalities in type 2 diabetic patients with optimal blood glucose control and optimal fasting triglyceride levels. J Clin Endocrinol Metab. 2004 May;89(5):2153-9.

Lopez-Miranda J, Williams C, Lairon D. Dietary, physiological, genetic and pathological influences on postprandial lipid metabolism. Br J Nutr. 2007 Sep;98(3):458-73. Review.

Lairon D, Play B, Jourdheuil-Rahmani D. Digestible and indigestible carbohydrates: interactions with postprandial lipid metabolism. J Nutr Biochem. 2007 Apr;18(4):217-27. Epub 2006 Oct 31. Review.

Responsible Party:	Department of Clinical and Experimental Medicine Federico II University Naples ( Angela A. Rivellese, MD )
Study ID Numbers:	29102008
Study First Received:	November 10, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00789295
Health Authority:	Italy: Ethics Committee

Keywords provided by Federico II University:

Mediterranean diet
Postprandial lipids
Postprandial glucose
High fibre diet

Low- CHO diet
High MUFA diet
Dietary approach

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Congenital Abnormalities

ClinicalTrials.gov processed this record on January 16, 2009